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GB19083-2010

Chinese Standard: 'GB19083-2010'
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GB 19083-2010English70 Add to Cart 0--15 minutes. Auto immediate delivery. Technical requirements for protective face mask for medical use Valid GB 19083-2010
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GB 19083-2010
ICS 11.100
C 44
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing GB 19083-2003
Technical Requirements for Protective Face
Mask for Medical Use
医用防护口罩技术要求
ISSUED ON: SEPTEMBER 2, 2010
IMPLEMENTED ON: AUGUST 1, 2011
Jointly issued by: The General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ);
Standardization Administration Committee (SAC) of The
People’s Republic of China.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative References ... 4 
3 Terms and Definitions ... 6 
4 Technical Requirements ... 6 
5 Test Methods ... 8 
6 Markings and Instructions for Use ... 11 
7 Packaging And Storage ... 13 
Appendix A (Informative) Preparation of Synthetic Blood ... 14 
Appendix B (Normative) Fitness Test Method ... 16 
References and Original Chinese Documents ... 19 
Foreword
In this Standard, Section 4.10 is recommendatory and other Sections are mandatory.
This Standard replaces GB 19083-2003 "Technical Requirements for Protective Face
Mask for Medical Use".
Compared with GB 19083-2003, this Standard has the major changes detailed as follows:
——The applicable “Scope” of the standard was revised;
——The "Normative References” was supplemented and revised;
——The terms and definitions were added and changed;
——The dimensional requirement of mask was deleted;
——The length requirement of nasal splint was deleted;
——The "Fit" requirement and test method were added;
——The technical requirement of "Skin irritation" was revised according to GB/T
16886.10-2005 and the test method was defined;
——The technical requirement of markings and instructions for use was deleted;
——The original test method for oxirane residue specified in GB 15980-1995 was
replaced by the gas chromatography method of GB/T 14233.1-2008;
——The test method of microorganism indexes was revised.
In this Standard, Appendix B is normative and Appendix A is informative.
This Standard was proposed by State Food and Drug Administration.
This Standard is under the jurisdiction of the National Technical Committee on Clinical
Laboratory Testing and Invitro Diagnostic Test Systems of Standardization Administration of
China.
Drafting organization of this Standard: Beijing Institute of Medical Device Testing
Chief drafting staffs of this Standard: Su Jian, Bi Chunlei, Liao Xiaoman and Zhang
Zhaoyuan.
The previous standard replaced by this standard is:
——GB 19083-2003.
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
中华人民共和国国家标准
Replace 19083-2003
Technical Requirements for Protective Face Mask
for Medical Use
医用防护口罩技术要求
1 Scope
This Standard specifies the technical requirements, test methods, markings and
instructions for use, packaging, transportation and storage for protective face mask for
medical use (hereinafter referred as mask).
This Standard is applicable to non-powered air-purifying medical protective face mask -
used in medical service environments to filter particulate matters in air and to separate spray,
blood, body fluid, secretion, etc.
2 Normative References
Those provisions contained in following documents, through quotation of this Standard,
constitute the provisions of this Standard. For dated document, subsequent amendments
(excluding the corrections) or revisions of the document do not apply. However, parties who
have signed agreement based on these standards are encouraged to investigate the possibility
of adopting the most recent editions of the standards indicated below (subsequent
amendments or revisions). For any undated documents, the latest edition of the document
applies.
GB/T 191 Packaging-Pictorial Marking for Handling of Goods
GB/T 2428-1998 Head-face Dimensions of Adults
GB/T 4745-1997 Textile Fabrics-Determination of Resistance to Surface Wetting-Spray
Test
GB/T 5549-1990 Surface Active Agents Determination of Surface Tension by Drawing
up Liquid Films
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for
Medical Use-Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipment for
Medical Use-Part 2: Biological Test Methods
GB 15979-2002 Hygienic Standard for Disposable Sanitary Products
GB/T 16886.10-2005 Biological Evaluation of Medical Devices-Part 10: Tests for
Irritation and Delayed-type Hypersensitivity
GB/T 18664-2002 Selection, Use and Maintenance of Respiratory Protective......
Related standard:   GB/T 29791.1-2013  GB/T 29791.2-2013
   
 
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